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Lyrica (Pregabalin) Administered as an Add-on Therapy for Partial Seizures (LEADER). (LEADER)

Primary Purpose

Epilepsy

Status
Completed
Phase
Phase 4
Locations
Greece
Study Type
Interventional
Intervention
Pregabalin
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Pregabalin for partial seizures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Outpatients equal to or greater than 18 years of age with diagnosis of epilepsy with partial seizures having minimum of two partial seizures during a two month period before the baseline visit Having a clinical history of epilepsy and AED treatment at least 1 year prior to inclusion Exclusion Criteria: AED or Seizures/Epilepsy Related Exclusions:having a treatable cause of seizures Having absences seizures Having had status epileptics within the year prior to inclusion Having a progressive neurological or systematic disorder Having known significant renal or hepatic dysfunction

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

Primary Outcome Measures

Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the 12 Week Observation Period
Percentage change from baseline=[(12 week treatment observation period seizure frequency rate minus 8 week baseline period seizure frequency rate)/ 8 week baseline period seizure frequency rate] x 100. Seizure frequencies per 28-day period: = (total # of partial seizures in period x 28 / (total # of days in period).

Secondary Outcome Measures

Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the Whole 21 Week Open-label Treatment Period.
Percentage change from baseline = ((21 weeks-8 weeks)/8 weeks)*100. Negative mean R-Ratios and associated 95% CIs that do not include zero indicate reduction in partial seizure frequency.
Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between the 8 Week Baseline Period and 4 Week Intervals During the 21 Week Open-label Treatment Period.
Percentage change from baseline = [(4 week seizure frequency minus 8 week baseline) / (8 week baseline seizure frequency)] x 100. Negative mean R-Ratios and associated 95% CIs that do not include zero indicate reduction in partial seizure frequency.
Number of Subjects Seizure-free
Count of subjects seizure free during the period.
Reduction in Partial Seizure Frequency Between Baseline and the Final 4 Weeks of the Observation Period.
Number of subjects with at least a 50% or 75% reduction in partial seizure frequency between baseline and treatment period.
Subjects Achieving Seizure Freedom During Observation Period
Number of subjects achieving seizure freedom (no seizures) during last 4 weeks or duration of 12 week observation period.
Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the 12 Week Observation Period Categorized by Baseline Seizure Frequency
Percentage change from baseline = ((12 weeks - 8 weeks)/8 weeks)*100. Negative mean R-Ratios and associated 95% CIs that do not include zero indicate reduction in partial seizure frequency.
Impression of Change in Overall Status Using the Patient Global Impression of Change (PGIC)
The PGIC is a patient-rated instrument that measures change in patient's overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).
Subjects With Categorical Impression of Change in Overall Status Using the Clinical Global Impression of Change (CGIC)
The CGIC is a clinician's judgment of the overall change in the patient's condition over a defined period on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).
Changes From Baseline in Medical Outcomes Study (MOS) Sleep Scale Scores
Subjects recall sleep related activities over the previous 4 weeks. Low scores reflect greater impairment (except sleep adequacy, optimal sleep, &quantity). Range = 0 - 100 for Sleep Disturbance, Snoring, Awaken Short of Breath, Sleep Adequacy, Somnolence, & Sleep Problems Index. Quantity of Sleep Range = 0 - 24. Optimal Sleep Range 0 - 1.
Change From Baseline in Hospital Anxiety and Depression Scale(HADS) Depression and Anxiety Symptoms Subscales Between Baseline and Week 21.
Change in total HADS score between Baseline and Week 21. Each of the 14 items is scored 0, 1, 2 or 3 where a score of 3 corresponds to the most anxious/depressed. 7-item depression and 7-item anxiety subscales are summed; each resulting in a total score of 0-21.
Number of Subjects With a Weight Gain at End of Treatment of at Least 7% Relative to Baseline
Count of subjects with a weight gain of at least 7 percent relative to baseline.
Subjects Assessment of Optimal Sleep
Number of subjects that responded optimal or non-optimal sleep in Optimal Sleep subscale of Medical Outcomes Study (MOS) Sleep scale.

Full Information

First Posted
February 7, 2006
Last Updated
January 20, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00288639
Brief Title
Lyrica (Pregabalin) Administered as an Add-on Therapy for Partial Seizures (LEADER).
Acronym
LEADER
Official Title
Lyrica (Pregabalin) Administered As An Add-On Therapy For Partial Seizures (LEADER) An Open-Label, Multicenter Add-On Therapy Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of study is to assess the clinical improvement (change in seizure frequency), safety, and tolerability of subjects with partial seizures following adjunctive therapy of pregabalin BID (150 to 600 mg/day titration) in addition to existing standards AEDs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Pregabalin for partial seizures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Pregabalin
Intervention Description
Pregabalin treatment, given as 2 divided doses, is initiated at a dose of 150 mg/day (75 mg BID). Based on individual subject response and tolerability, the dosage may be increased to 300 mg/day after 1 week (150 mg BID given as two 75-mg capsules BID). Based on subjects individual response and tolerability, dosage can be incrementally increased further after an additional week to 600 mg/day (300 mg BID given as four 75-mg capsules BID).
Primary Outcome Measure Information:
Title
Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the 12 Week Observation Period
Description
Percentage change from baseline=[(12 week treatment observation period seizure frequency rate minus 8 week baseline period seizure frequency rate)/ 8 week baseline period seizure frequency rate] x 100. Seizure frequencies per 28-day period: = (total # of partial seizures in period x 28 / (total # of days in period).
Time Frame
8 week baseline period & 12 week treatment observation period
Secondary Outcome Measure Information:
Title
Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the Whole 21 Week Open-label Treatment Period.
Description
Percentage change from baseline = ((21 weeks-8 weeks)/8 weeks)*100. Negative mean R-Ratios and associated 95% CIs that do not include zero indicate reduction in partial seizure frequency.
Time Frame
8 week baseline period and 21 week treatment period
Title
Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between the 8 Week Baseline Period and 4 Week Intervals During the 21 Week Open-label Treatment Period.
Description
Percentage change from baseline = [(4 week seizure frequency minus 8 week baseline) / (8 week baseline seizure frequency)] x 100. Negative mean R-Ratios and associated 95% CIs that do not include zero indicate reduction in partial seizure frequency.
Time Frame
8 week baseline period and 21 week treatment period
Title
Number of Subjects Seizure-free
Description
Count of subjects seizure free during the period.
Time Frame
last 4 weeks & whole 12 week treatment observation period
Title
Reduction in Partial Seizure Frequency Between Baseline and the Final 4 Weeks of the Observation Period.
Description
Number of subjects with at least a 50% or 75% reduction in partial seizure frequency between baseline and treatment period.
Time Frame
8 week baseline observation period & last 4 weeks of observation period
Title
Subjects Achieving Seizure Freedom During Observation Period
Description
Number of subjects achieving seizure freedom (no seizures) during last 4 weeks or duration of 12 week observation period.
Time Frame
Day 147 from the first dose of study drug
Title
Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the 12 Week Observation Period Categorized by Baseline Seizure Frequency
Description
Percentage change from baseline = ((12 weeks - 8 weeks)/8 weeks)*100. Negative mean R-Ratios and associated 95% CIs that do not include zero indicate reduction in partial seizure frequency.
Time Frame
8 week baseline observation period & 12 week treatment observation period
Title
Impression of Change in Overall Status Using the Patient Global Impression of Change (PGIC)
Description
The PGIC is a patient-rated instrument that measures change in patient's overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).
Time Frame
End of 21-week treatment
Title
Subjects With Categorical Impression of Change in Overall Status Using the Clinical Global Impression of Change (CGIC)
Description
The CGIC is a clinician's judgment of the overall change in the patient's condition over a defined period on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).
Time Frame
End of 21-week treatment
Title
Changes From Baseline in Medical Outcomes Study (MOS) Sleep Scale Scores
Description
Subjects recall sleep related activities over the previous 4 weeks. Low scores reflect greater impairment (except sleep adequacy, optimal sleep, &quantity). Range = 0 - 100 for Sleep Disturbance, Snoring, Awaken Short of Breath, Sleep Adequacy, Somnolence, & Sleep Problems Index. Quantity of Sleep Range = 0 - 24. Optimal Sleep Range 0 - 1.
Time Frame
Baseline, end of 21-week treatment
Title
Change From Baseline in Hospital Anxiety and Depression Scale(HADS) Depression and Anxiety Symptoms Subscales Between Baseline and Week 21.
Description
Change in total HADS score between Baseline and Week 21. Each of the 14 items is scored 0, 1, 2 or 3 where a score of 3 corresponds to the most anxious/depressed. 7-item depression and 7-item anxiety subscales are summed; each resulting in a total score of 0-21.
Time Frame
Baseline, End of 21-week treatment
Title
Number of Subjects With a Weight Gain at End of Treatment of at Least 7% Relative to Baseline
Description
Count of subjects with a weight gain of at least 7 percent relative to baseline.
Time Frame
Baseline, End of 21-week treatment
Title
Subjects Assessment of Optimal Sleep
Description
Number of subjects that responded optimal or non-optimal sleep in Optimal Sleep subscale of Medical Outcomes Study (MOS) Sleep scale.
Time Frame
Baseline, End of 21-week treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Outpatients equal to or greater than 18 years of age with diagnosis of epilepsy with partial seizures having minimum of two partial seizures during a two month period before the baseline visit Having a clinical history of epilepsy and AED treatment at least 1 year prior to inclusion Exclusion Criteria: AED or Seizures/Epilepsy Related Exclusions:having a treatable cause of seizures Having absences seizures Having had status epileptics within the year prior to inclusion Having a progressive neurological or systematic disorder Having known significant renal or hepatic dysfunction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Athens
ZIP/Postal Code
11526
Country
Greece
Facility Name
Pfizer Investigational Site
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Pfizer Investigational Site
City
Heraklio
ZIP/Postal Code
71110
Country
Greece
Facility Name
Pfizer Investigational Site
City
Mesogion, Athen
ZIP/Postal Code
15125
Country
Greece
Facility Name
Pfizer Investigational Site
City
Patras
ZIP/Postal Code
26500
Country
Greece
Facility Name
Pfizer Investigational Site
City
Thessaloniki
ZIP/Postal Code
54636
Country
Greece
Facility Name
Pfizer Investigational Site
City
Thessaloniki
ZIP/Postal Code
57010
Country
Greece
Facility Name
Pfizer Investigational Site
City
Thessaloniki
Country
Greece

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081088&StudyName=Lyrica%20%28Pregabalin%29%20Administered%20in%20as%20an%20Add-on%20Therapy%20for%20Partial%20Seizures%20%28LEADER%29.%20
Description
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Lyrica (Pregabalin) Administered as an Add-on Therapy for Partial Seizures (LEADER).

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